Regulatorische Updates

The FDA has approved Mylan Pharmaceuticals' sumatriptan succinate tablets (25 mg, 50 mg, 100 mg) under ANDA 077744, with multiple labeling submissions recorded.

The FDA has approved two prescription oral tablets combining irbesartan and hydrochlorothiazide under ANDA 077446, with multiple labeling supplements approved.

The FDA has approved ANDA076568 for Nicotine Polacrilex chewing gum, an over‑the‑counter nicotine replacement product available in 4 mg and 2 mg strengths.

FDA granted approval (ANDA076850) for Fougera Pharms' terconazole 80 mg vaginal suppository, now listed as discontinued.

The FDA approved ANDA076296 for a Vincristine Sulfate injectable (1 mg/mL) submitted by Fresenius Kabi USA. The product is listed as discontinued.

FDA has approved an ANDA for buprenorphine sublingual tablets (2 mg and 8 mg) from Hikma Pharmaceuticals USA Inc., with associated labeling and REMS submissions.

The FDA approved ANDA085034 for ALPHAZINE, a 35 mg phendimetrazine tartrate oral tablet by Sandoz, with original and supplemental approvals spanning 1978‑1991.

FDA approved ANDA 084553 for COMPOUND 65, an oral capsule containing aspirin 389 mg, caffeine 32.4 mg, and propoxyphene HCl 65 mg; sponsor ALRA; product listed as discontinued.

FDA approved labeling and manufacturing submissions for ANDA081008 covering the oral tablet STRIFON FORTE DSC (500 mg chlorzoxazone) by Fern Dale Labs; the product is now discontinued.

The FDA has granted approval for Alembic Pharmaceuticals’ generic lithium carbonate oral capsules in 150 mg, 300 mg, and 600 mg strengths under ANDA 079159.

The FDA has approved ANDA078845 for a 600 mg oral linezolid tablet marketed by Rising Pharma Holdings, Inc.

The FDA has marked the testosterone injectable (product 001) as discontinued, with a record of multiple labeling and manufacturing submissions dating back to 1983.